ELLECOS 2% Vaginal cream

Зміст інструкції

1. ELLECOS 2% vaginal cream
   1. What is ELLECOS and what is it used for
   2. What you need to know before using ELLECOS
   3. How to use ELLECOS
   4. Possible side effects
   5. How to store ELLECOS
   6. Contents of the pack and other information

ELLECOS 2% vaginal cream

clotrimazolo

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What ELLECOS is and what it is used for
• 2. What you need to know before using ELLECOS
• 3. How to use ELLECOS
• 4. Possible side effects
• 5. How to store ELLECOS
• 6. Contents of the pack and other information

1. What is ELLECOS and what is it used for

ELLECOS contains clotrimazole, an antifungal agent that inhibits fungal growth.
ELLECOS is used, in adults and adolescents over the age of 12 years, for the treatment of localised symptoms
resulting from vulvovaginal and glans (distal portion of the penis) infections caused by candida,
previously diagnosed. These symptoms include itching, leukorrhea (whitish vaginal discharge),
redness and a feeling of swelling of the vaginal mucosa and glans, burning during urination.
See your doctor if you do not feel better or if you feel worse after 7 days of treatment.

2. What you need to know before using ELLECOS

Do not use ELLECOS

• if you are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using ELLECOS if:

• you have already suffered from the same disorders less than 2 months ago
• you have a fever, lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain.

The use, especially if prolonged, of topical products (applied to the skin), can cause sensitization (acquisition of greater sensitivity); in this case it is necessary to interrupt the treatment and consult your doctor or pharmacist.
Avoid contact with eyes. Do not ingest.
It is preferable to start and end the treatment during the intermenstrual period.
During the use of this medicine avoid vaginal intercourse, because the infection could be transmitted to your partner.
Furthermore, in order to avoid reinfection, particularly in the presence of vulvitis or balanitis due to Candida, local treatment of the partner is recommended.
During therapy with ELLECOS do not use tampons, vaginal douches, spermicides or other vaginal products.
During treatment with ELLECOS, the effectiveness and safety of latex products, such as condoms and diaphragms, may be reduced.

Children and adolescents
This medicine should not be used by children under 12 years of age.

Other medicines and ELLECOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor in particular if you are being treated with sirolimusor oral tacrolimus(used to prevent organ transplant rejection) as ELLECOS may increase the levels of sirolimus and tacrolimus in the blood. In this case, your doctor will carefully monitor your condition.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Clinical data available regarding risk in pregnancy are limited. ELLECOS may be used during pregnancy only if absolutely necessary and under the supervision of a doctor.

Breastfeeding
ELLECOS can be used during breastfeeding.

Fertility
No studies have been conducted in humans on the effects of clotrimazole on fertility, however studies in animals have not shown any reproductive toxicity effects.

Driving and operating machinery
The medicine does not alter or negligibly alters the ability to drive vehicles or operate machinery.

ELLECOS contains cetostearyl alcohol and benzyl alcohol
This medicine contains cetostearyl alcohol: it may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg of benzyl alcoholper dose, equivalent to 20 mg/g.
Benzyl alcohol can cause allergic reactions and mild local irritation.

3. How to use ELLECOS

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents over the age of 12 years
Introduce the contents of one applicator (approximately 5 g) as deeply as possible into the vagina, once a day, preferably in the evening, at bedtime, for 3 consecutive days.
If necessary, the treatment can be extended for another 3 days.
If your doctor has told you that you have vulvitisor Candida balanitis, apply a thin layer of ELLECOS
2-3 times a day to the entire urogenital and anal area.
In order to avoid re-infection, in particular in the presence of vulvitis or Candida balanitis, the partner must be treated locally at the same time, applying the cream to the prepuce (skin covering the glans, the most distal portion of the penis). Facilitate the absorption of the cream locally with a gentle
massage.

Duration of treatment
The maximum treatment duration is 7 days. If symptoms persist, consult your doctor.
In case of vulvitis or balanitis, the treatment should be extended for 1-2 weeks.

Method of use

• 1. Remove the plunger from the single-use applicator

until it stops.

• 2. Open the tube. Screw the single-use applicator onto it and hold it firmly. Fill the applicator by applying gentle pressure on the tube.
• 3. Once you have assumed a supine position (lying on your back) with your legs slightly bent, remove the single-use applicator, introduce it as deeply as possible into the vagina and empty it by applying regular and continuous pressure on the plunger.
• 4. Remove the applicator and then discard it.

The applicator must be used only once and then discarded, in order to avoid possible re-infections.
Health education notes
It is important to follow some personal hygiene rules for prevention:

• avoid wearing overly tight clothing;
• avoid wearing nylon or other synthetic fiber underwear: preferably use cotton or natural fiber clothing;
• avoid using alkaline pH soaps for intimate hygiene: the use of acidic pH (pH 5) detergents is recommended to respect the normal acidity of the vaginal environment;
• avoid using vaginal douches which can alter the vaginal environment and therefore promote

the establishment of infections;

• if using tampons, change them frequently and avoid use during the night; it is still preferable to use external sanitary pads.

If you use more ELLECOS than you should
There is no risk of acute intoxication since it is unlikely to occur after a single vaginal or cutaneous application of an excessive dose (application to a large area under favorable absorption conditions) or accidental oral intake. There is no
specific antidote. In case of ingestion/accidental intake of an excessive dose of ELLECOS, immediately inform your doctor or go to the nearest hospital.

If you forget to use ELLECOS
Continue the treatment as prescribed.
If you have any doubts about the use of ELLECOS, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of this medicine, the following side effects may occur with unknown frequency (frequency cannot be
estimated based on available data):

• anaphylactic reaction (severe allergic reaction),
• angioedema (swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and
  swallowing),
• hypersensitivity (allergy),
• syncope (fainting),
• hypotension (low blood pressure).
• dyspnea (difficulty breathing),
• abdominal pain,
• nausea,
• skin rash,
• urticaria (hives),
• exfoliation in the genital area,
• vaginal discharge,
• vaginal bleeding,
• discomfort in the genital area,
• erythema (redness) in the genital area,
• burning sensation in the genital area,
• itching in the genital area,
• pain in the genital area,
• irritation, edema (fluid retention) and pain at the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help to provide
more information on the safety of this medicine.

5. How to store ELLECOS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Do not use ELLECOS 2% cream after 3 months from first opening.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the box

6. Contents of the pack and other information

What ELLECOS contains

• The active ingredient is clotrimazole. 5 g of vaginal cream contains 100 mg of clotrimazole.
• The other ingredients are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of ELLECOS and contents of the pack
ELLECOS is presented in the form of a homogeneous vaginal cream, from white to off-white in color, for gynecological use.
The pack contains a 30 g aluminum tube of vaginal cream with 6 single-use applicators.

Marketing authorization holder and manufacturer
Marketing authorization holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)